Low-grade Chronic InflammationDASINCT01424306
Diet and Systemic Inflammation
A study testing Fructose-sweetened beverages, Glucose-sweetened beverages and High-fructose corn syrup-sweetened beverages in people with Low-grade Chronic Inflammation and Intestinal Permeability, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
People with chronic low-grade inflammation have a higher risk for certain diseases such as cardiovascular disease or type 2 diabetes. While it is known that obese people are more likely to show signs of low-grade inflammation than lean individuals, it is unclear what causes this inflammation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low-grade Chronic Inflammation, Intestinal Permeability, Type 2 Diabetes Mellitus
- What is being tested?
- Fructose-sweetened beverages, Glucose-sweetened beverages and High-fructose corn syrup-sweetened beverages
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Apr 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18-65 years;
- BMI 20-40 kg/m2;
- Weight stable to within 10 pounds for 6 months prior to entering the study, and at their lifetime maximum weight (or within 30 pounds of it; excluding pregnancy);
- Ability to be admitted for ~30 minutes on three occasions, and ~6 hours on three occasions to the FHCRC Prevention Center;
- Ability to provide informed written consent;
- Willingness to consume only food and beverages provided by the Human Nutrition Laboratory of the FHCRC Prevention Center for three periods of 8 days each.
Who cannot join
- Presence or history of chronic inflammatory, autoimmune or metabolic diseases;
- Presence of phenylketonuria, hereditary fructose intolerance, fructose malabsorption, or malabsorption syndromes;
- Abuse of alcohol (>2 drinks per day), smoking, or use of recreational drugs;
- Current or recent (within three months) intake of medications likely to interfere with study endpoints (insulin, antidiabetics, β-blockers, anabolic steroids, glucocorticosteroids, daily high-dose non-steroidal anti-inflammatory drugs, warfarin, antibiotics, probiotics);
- Presence of anemia, recent (within 2 months) history of anemia;
- Anyone not willing or able to eat the provided food;
- Current or recent (within 12 months) pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
People with chronic low-grade inflammation have a higher risk for certain diseases such as cardiovascular disease or type 2 diabetes. While it is known that obese people are more likely to show signs of low-grade inflammation than lean individuals, it is unclear what causes this inflammation. In the proposed study, the investigators will examine whether the sugar fructose, when consumed in a sweetened beverage, triggers low-grade inflammation in healthy men and women compared with other caloric sweeteners.
Read the detailed description
The objective of this proposal is to investigate whether fructose-sweetened beverages trigger low-grade systemic inflammation in healthy men and women. Low-grade systemic inflammation, specifically elevated plasma concentrations of C-reactive protein (CRP), is a risk factor for cardiovascular disease (CVD). While it is known that obesity is associated with inflammation, the causes of low-grade inflammation in humans are not well understood. In a pilot study, the consumption of large amounts of fructose-, but not glucose- or aspartame-sweetened beverages potently induced low-grade inflammation in healthy, lean, young men and women in as little as 8 days. The investigators propose to extend these findings by (a) enrolling a greater number of subjects, (b) enrolling obese as well as non-obese subjects, and (c) including a beverage that is sweetened with high fructose corn syrup (HFCS). HFCS is one of the primary sugars consumed in the United States, and a major source of dietary fructose. Our primary specific aim is to assess whether the consumption of fructose- or HFCS-sweetened beverages promotes systemic low-grade inflammation, as measured by plasma concentrations of CRP and IL-6. The investigators hypothesize that plasma CRP and IL-6 concentrations will be elevated after consumption of fructose-containing beverages (fructose and HFCS) when compared to a glucose-sweetened beverage. Our secondary specific aim is to assess whether the consumption of fructose- or HFCS-sweetened beverages lowers plasma adiponectin concentrations. Specifically, the investigators hypothesize that total and high molecular weight (HMW)-adiponectin concentrations in fasting plasma will be lower after subjects have consumed the fructose- or HFCS-sweetened beverages, compared to a glucose-sweetened beverage.
The investigators will recruit 12 overweight/obese (BMI between 25.0 and 40 kg/m2) and 12 normal weight (BMI between 20 and 24.9 kg/m2) men and women who are free of chronic inflammatory or metabolic disease. In a double-blind, randomized cross-over design, each subject will complete three 8-day standardized dietary periods that will differ only in the type of sweetened beverage administered. Specifically, subjects will be asked to drink four servings of a beverage each day that is sweetened with glucose, fructose, or HFCS (55% fructose, 45% glucose). All solid food will be provided for each of the three 8-day diet periods, and will be consumed ad libitum. Following each dietary period, the investigators will collect fasting blood to measure markers of systemic inflammation and plasma concentrations of total and HMW-adiponectin. We will also assess changes in adipose tissue inflammation and intestinal permeability as potential mechanisms by which fructose-sweetened beverages may trigger systemic inflammation. This study has the potential to identify a dietary trigger of low-grade inflammation, a likely contributor to CVD and metabolic diseases. The public health impact of this project might be considerable given that the consumption of fructose in the population is pervasive, and is modifiable on an individual as well as a population level.
- Conditions
- Low-grade Chronic Inflammation, Intestinal Permeability, Type 2 Diabetes Mellitus, Cardiovascular Disease, Obesity
- Being tested
- Fructose-sweetened beverages, Glucose-sweetened beverages, High-fructose corn syrup-sweetened beverages
- Keywords
- Inflammation, Intestinal permeability, Type 2 diabetes mellitus, Cardiovascular disease, Obesity, Sweetened beverages, Sugar, Fructose, Glucose, High-fructose corn syrup
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fructose-sweetened beveragesOther
In addition to consuming a standardized diet, subjects will be asked to consume 4 servings per day of a fructose-sweetened beverage for 8 days. The amount of fructose consumed will be 25% of the subject's estimated daily calorie requirement.
Glucose-sweetened beveragesOther
In addition to consuming a standardized diet, subjects will be asked to consume 4 servings per day of a glucose-sweetened beverage for 8 days. The amount of glucose consumed will be 25% of the subject's estimated daily calorie requirement.
High-fructose corn syrup-sweetened beveragesOther
In addition to consuming a standardized diet, subjects will be asked to consume 4 servings per day of a high-fructose corn syrup-sweetened beverage for 8 days. The amount of high-fructose corn syrup consumed will be 25% of the subject's estimated daily calorie requirement.
| Study group | Role | What they receive |
|---|---|---|
| Fructose-sweetened beverages | Experimental | In addition to consuming a standardized diet, subjects will be asked to consume 4 servings per day of a fructose-sweetened beverage for 8 days. Receives: Other: Fructose-sweetened beverages |
| Glucose-sweetened beverages | Experimental | In addition to consuming a standardized diet, subjects will be asked to consume 4 servings per day of a glucose-sweetened beverage for 8 days. Receives: Other: Glucose-sweetened beverages |
| High-fructose corn syrup-sweetened beverages | Experimental | In addition to consuming a standardized diet, subjects will be asked to consume 4 servings per day of a high-fructose corn syrup-sweetened beverage for 8 days. Receives: Other: High-fructose corn syrup-sweetened beverages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Plasma C-reactive Protein
The concentration of C-reactive protein in fasting plasma will be measured by high-sensitivity assay at the beginning (day 1) and end (day 9) of each 8-day dietary period.
Measured: Beginning (day 1) and end (day 9) of each diet period.
Fasting Plasma Interleukin-6 on Day 9 of Each Diet Period
The concentration of interleukin-6 in fasting plasma will be measured by high-sensitivity enzyme-linked immunosorbent assay at the end (day 9) of each 8-day dietary period.
Measured: End (day 9) of each diet period
Secondary outcomes (11)
Fasting Plasma Adiponectin
The concentration of adiponectin in fasting plasma will be measured by enzyme-linked immunosorbent assay at the end (day 9) of each 8-day dietary period.
Measured: End (day 9) of each diet period.
Mean Daily Calorie Intake
Mean daily calorie intake will be assessed during each of the three 8-day diet periods. All foods will be provided to the subjects in excess of what they are estimated to require, and calorie intake will be assessed by subtracting returned foods from foods administered.
Measured: The mean daily calorie intake during each of the 8-day diet periods will be calculated.
Intestinal Permeability, as Assessed by the 5-hour Urinary Lactulose/Mannitol Test
Intestinal permeability will be assessed on day 9 of each diet period by administering a beverage containing 2 g of mannitol and 5 g of lactulose followed by collecting urine for 5 hours afterwards. Recovery of mannitol and lactulose in urine will be measured by gas chromatography, and will be indicative of the degree of intestinal permeability.
Measured: End (day 9) of each diet period.
Fasting Plasma Zonulin Concentrations
Zonulin concentrations will be measured by enzyme-linked immunosorbent assay in fasting plasma collected on day 9 of each diet period. Plasma zonulin is a marker of intestinal permeability.
Measured: End (day 9) of each diet period.
Fasting Plasma Lipopolysaccharide-binding Protein (LBP)
Lipopolysaccharide-binding protein (LBP) will be measured by enzyme-linked immunosorbent assay in fasting plasma collected on day 9 of each diet period. LBP is an acute phase protein secreted by the liver in response to endotoxin (lipopolysaccharide) exposure.
Measured: End (day 9) of each diet period.
Adipose Tissue Inflammation - Tissue Expression of TNF-alpha mRNA
A subgroup of the study population will be enrolled into an ancillary study that will aim to assess the effects of consuming fructose- vs. high-fructose corn syrup- vs. glucose-sweetened beverages on adipose tissue inflammation. Adipose tissue inflammation will be assessed by whole adipose tissue gene expression analysis of TNF-alpha mRNA. Abdominal subcutaneous adipose tissue samples will be obtained from subjects enrolled into the ancillary study by needle aspiration biopsy on day 9 of each 8-day dietary period.
Measured: End (day 9) of each diet period.
Adipose Tissue Inflammation - Tissue Expression of IL-1beta mRNA
A subgroup of the study population will be enrolled into an ancillary study that will aim to assess the effects of consuming fructose- vs. high-fructose corn syrup- vs. glucose-sweetened beverages on adipose tissue inflammation. Adipose tissue inflammation will be assessed by whole adipose tissue gene expression analysis of IL-1beta mRNA. Abdominal subcutaneous adipose tissue samples will be obtained from subjects enrolled into the ancillary study by needle aspiration biopsy on day 9 of each 8-day dietary period.
Measured: End (day 9) of each diet period.
Adipose Tissue Inflammation - Tissue Expression of IL-6 mRNA
A subgroup of the study population will be enrolled into an ancillary study that will aim to assess the effects of consuming fructose- vs. high-fructose corn syrup- vs. glucose-sweetened beverages on adipose tissue inflammation. Adipose tissue inflammation will be assessed by whole adipose tissue gene expression analysis of IL-6 mRNA. Abdominal subcutaneous adipose tissue samples will be obtained from subjects enrolled into the ancillary study by needle aspiration biopsy on day 9 of each 8-day dietary period.
Measured: End (day 9) of each diet period.
Adipose Tissue Inflammation - Tissue Expression of IL-10 mRNA
A subgroup of the study population will be enrolled into an ancillary study that will aim to assess the effects of consuming fructose- vs. high-fructose corn syrup- vs. glucose-sweetened beverages on adipose tissue inflammation. Adipose tissue inflammation will be assessed by whole adipose tissue gene expression analysis of IL-10 mRNA. Abdominal subcutaneous adipose tissue samples will be obtained from subjects enrolled into the ancillary study by needle aspiration biopsy on day 9 of each 8-day dietary period.
Measured: End (day 9) of each diet period.
Adipose Tissue Inflammation - Tissue Expression of CCL2 mRNA
A subgroup of the study population will be enrolled into an ancillary study that will aim to assess the effects of consuming fructose- vs. high-fructose corn syrup- vs. glucose-sweetened beverages on adipose tissue inflammation. Adipose tissue inflammation will be assessed by whole adipose tissue gene expression analysis of CCL2 mRNA. Abdominal subcutaneous adipose tissue samples will be obtained from subjects enrolled into the ancillary study by needle aspiration biopsy on day 9 of each 8-day dietary period.
Measured: End (day 9) of each diet period.
Adipose Tissue Inflammation - Tissue Expression of IFN-gamma mRNA
A subgroup of the study population will be enrolled into an ancillary study that will aim to assess the effects of consuming fructose- vs. high-fructose corn syrup- vs. glucose-sweetened beverages on adipose tissue inflammation. Adipose tissue inflammation will be assessed by whole adipose tissue gene expression analysis of IFN-gamma mRNA. Abdominal subcutaneous adipose tissue samples will be obtained from subjects enrolled into the ancillary study by needle aspiration biopsy on day 9 of each 8-day dietary period.
Measured: End (day 9) of each diet period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low-grade Chronic InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Kratz, Fred Hutchinson Cancer Center
- Investigators
- Mario Kratz, MS, PhD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424306
- Sponsor's protocol ID
- NHLBI R21 HL108257
- Other IDs
- R21HL108257
- Acronym
- DASI
- Status last verified
- Jul 2017
- First submitted
- 24 Aug 2011
- Last updated
- 14 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kuzma JN, Cromer G, Hagman DK, Breymeyer KL, Roth CL, Foster-Schubert KE, Holte SE, Callahan HS, Weigle DS, Kratz M. No difference in ad libitum energy intake in healthy men and women consuming beverages sweetened with fructose, glucose, or high-fructose corn syrup: a randomized trial. Am J Clin Nutr. 2015 Dec;102(6):1373-80. doi: 10.3945/ajcn.115.116368. Epub 2015 Nov 4.
PubMed 26537945Kuzma JN, Cromer G, Hagman DK, Breymeyer KL, Roth CL, Foster-Schubert KE, Holte SE, Weigle DS, Kratz M. No differential effect of beverages sweetened with fructose, high-fructose corn syrup, or glucose on systemic or adipose tissue inflammation in normal-weight to obese adults: a randomized controlled trial. Am J Clin Nutr. 2016 Aug;104(2):306-14. doi: 10.3945/ajcn.115.129650. Epub 2016 Jun 29.
PubMed 27357093
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet and Systemic Inflammation
- ClinicalTrials.gov ID
- NCT01424306
- Acronym / sponsor ID
- DASI / NHLBI R21 HL108257
- Conditions
- Low-grade Chronic Inflammation, Intestinal Permeability, Type 2 Diabetes Mellitus, Cardiovascular Disease, Obesity
- Keywords
- Inflammation, Intestinal permeability, Type 2 diabetes mellitus, Cardiovascular disease, Obesity, Sweetened beverages, Sugar, Fructose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Washington
- Study start
- Oct 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 26 Aug 2011 (estimated)
- Results
- Posted 14 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People with chronic low-grade inflammation have a higher risk for certain diseases such as cardiovascular disease or type 2 diabetes. While it is known that obese people are more likely to show signs of low-grade inflammation than lean individuals, it is unclear what causes this inflammation. In the proposed study, the investigators will examine whether the sugar fructose, when consumed in a sweetened beverage, triggers low-grade inflammation in healthy men and women compared with other caloric sweeteners.
Detailed description
The objective of this proposal is to investigate whether fructose-sweetened beverages trigger low-grade systemic inflammation in healthy men and women. Low-grade systemic inflammation, specifically elevated plasma concentrations of C-reactive protein (CRP), is a risk factor for cardiovascular disease (CVD). While it is known that obesity is associated with inflammation, the causes of low-grade inflammation in humans are not well understood. In a pilot study, the consumption of large amounts of fructose-, but not glucose- or aspartame-sweetened beverages potently induced low-grade inflammation in healthy, lean, young men and women in as little as 8 days. The investigators propose to extend these findings by (a) enrolling a greater number of subjects, (b) enrolling obese as well as non-obese subjects, and (c) including a beverage that is sweetened with high fructose corn syrup (HFCS). HFCS is one of the primary sugars consumed in the United States, and a major source of dietary fructose. Our primary specific aim is to assess whether the consumption of fructose- or HFCS-sweetened beverages promotes systemic low-grade inflammation, as measured by plasma concentrations of CRP and IL-6. The investigators hypothesize that plasma CRP and IL-6 concentrations will be elevated after consumption of fructose-containing beverages (fructose and HFCS) when compared to a glucose-sweetened beverage. Our secondary specific aim is to assess whether the consumption of fructose- or HFCS-sweetened beverages lowers plasma adiponectin concentrations. Specifically, the investigators hypothesize that total and high molecular weight (HMW)-adiponectin concentrations in fasting plasma will be lower after subjects have consumed the fructose- or HFCS-sweetened beverages, compared to a glucose-sweetened beverage.
The investigators will recruit 12 overweight/obese (BMI between 25.0 and 40 kg/m2) and 12 normal weight (BMI between 20 and 24.9 kg/m2) men and women who are free of chronic inflammatory or metabolic disease. In a double-blind, randomized cross-over design, each subject will complete three 8-day standardized dietary periods that will differ only in the type of sweetened beverage administered. Specifically, subjects will be asked to drink four servings of a beverage each day that is sweetened with glucose, fructose, or HFCS (55% fructose, 45% glucose). All solid food will be provided for each of the three 8-day diet periods, and will be consumed ad libitum. Following each dietary period, the investigators will collect fasting blood to measure markers of systemic inflammation and plasma concentrations of total and HMW-adiponectin. We will also assess changes in adipose tissue inflammation and intestinal permeability as potential mechanisms by which fructose-sweetened beverages may trigger systemic inflammation. This study has the potential to identify a dietary trigger of low-grade inflammation, a likely contributor to CVD and metabolic diseases. The public health impact of this project might be considerable given that the consumption of fructose in the population is pervasive, and is modifiable on an individual as well as a population level.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fructose-sweetened beverages | Experimental | Other: Fructose-sweetened beveragesIn addition to consuming a standardized diet, subjects will be asked to consume 4 servings per day of a fructose-sweetened beverage for 8 days. |
| Glucose-sweetened beverages | Experimental | Other: Glucose-sweetened beveragesIn addition to consuming a standardized diet, subjects will be asked to consume 4 servings per day of a glucose-sweetened beverage for 8 days. |
| High-fructose corn syrup-sweetened beverages | Experimental | Other: High-fructose corn syrup-sweetened beveragesIn addition to consuming a standardized diet, subjects will be asked to consume 4 servings per day of a high-fructose corn syrup-sweetened beverage for 8 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18-65 years;
- BMI 20-40 kg/m2;
- Weight stable to within 10 pounds for 6 months prior to entering the study, and at their lifetime maximum weight (or within 30 pounds of it; excluding pregnancy);
- Ability to be admitted for ~30 minutes on three occasions, and ~6 hours on three occasions to the FHCRC Prevention Center;
- Ability to provide informed written consent;
Key exclusion criteria (7 listed)
- Presence or history of chronic inflammatory, autoimmune or metabolic diseases;
- Presence of phenylketonuria, hereditary fructose intolerance, fructose malabsorption, or malabsorption syndromes;
- Abuse of alcohol (>2 drinks per day), smoking, or use of recreational drugs;
- Current or recent (within three months) intake of medications likely to interfere with study endpoints (insulin, antidiabetics, β-blockers, anabolic steroids, glucocorticosteroids, daily high-dose non-steroidal anti-inflammatory drugs, warfarin, antibiotics, probiotics);
- Presence of anemia, recent (within 2 months) history of anemia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fructose-sweetened beveragesIn addition to consuming a standardized diet, subjects will be asked to consume 4 servings per day of a fructose-sweetened beverage for 8 days. The amount of fructose consumed will be 25% of the subject's estimated daily calorie requirement. | Other | Fructose-sweetened beverages |
| Glucose-sweetened beveragesIn addition to consuming a standardized diet, subjects will be asked to consume 4 servings per day of a glucose-sweetened beverage for 8 days. The amount of glucose consumed will be 25% of the subject's estimated daily calorie requirement. | Other | Glucose-sweetened beverages |
| High-fructose corn syrup-sweetened beveragesIn addition to consuming a standardized diet, subjects will be asked to consume 4 servings per day of a high-fructose corn syrup-sweetened beverage for 8 days. The amount of high-fructose corn syrup consumed will be 25% of the subject's estimated daily calorie requirement. | Other | High-fructose corn syrup-sweetened beverages |
Primary outcome
Fasting Plasma C-reactive Protein
Time frame: Beginning (day 1) and end (day 9) of each diet period.
The concentration of C-reactive protein in fasting plasma will be measured by high-sensitivity assay at the beginning (day 1) and end (day 9) of each 8-day dietary period.
Fasting Plasma Interleukin-6 on Day 9 of Each Diet Period
Time frame: End (day 9) of each diet period
The concentration of interleukin-6 in fasting plasma will be measured by high-sensitivity enzyme-linked immunosorbent assay at the end (day 9) of each 8-day dietary period.
11 secondary outcomes
Fasting Plasma Adiponectin
Time frame: End (day 9) of each diet period.
Mean Daily Calorie Intake
Time frame: The mean daily calorie intake during each of the 8-day diet periods will be calculated.
Intestinal Permeability, as Assessed by the 5-hour Urinary Lactulose/Mannitol Test
Time frame: End (day 9) of each diet period.
Fasting Plasma Zonulin Concentrations
Time frame: End (day 9) of each diet period.
Fasting Plasma Lipopolysaccharide-binding Protein (LBP)
Time frame: End (day 9) of each diet period.
Adipose Tissue Inflammation - Tissue Expression of TNF-alpha mRNA
Time frame: End (day 9) of each diet period.
Adipose Tissue Inflammation - Tissue Expression of IL-1beta mRNA
Time frame: End (day 9) of each diet period.
Adipose Tissue Inflammation - Tissue Expression of IL-6 mRNA
Time frame: End (day 9) of each diet period.
Adipose Tissue Inflammation - Tissue Expression of IL-10 mRNA
Time frame: End (day 9) of each diet period.
Adipose Tissue Inflammation - Tissue Expression of CCL2 mRNA
Time frame: End (day 9) of each diet period.
Adipose Tissue Inflammation - Tissue Expression of IFN-gamma mRNA
Time frame: End (day 9) of each diet period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26537945Kuzma JN, Cromer G, Hagman DK, Breymeyer KL, Roth CL, Foster-Schubert KE, Holte SE, Callahan HS, Weigle DS, Kratz M. No difference in ad libitum energy intake in healthy men and women consuming beverages sweetened with fructose, glucose, or high-fructose corn syrup: a randomized trial. Am J Clin Nutr. 2015 Dec;102(6):1373-80. doi: 10.3945/ajcn.115.116368. Epub 2015 Nov 4.
- Background: PubMed 27357093Kuzma JN, Cromer G, Hagman DK, Breymeyer KL, Roth CL, Foster-Schubert KE, Holte SE, Weigle DS, Kratz M. No differential effect of beverages sweetened with fructose, high-fructose corn syrup, or glucose on systemic or adipose tissue inflammation in normal-weight to obese adults: a randomized controlled trial. Am J Clin Nutr. 2016 Aug;104(2):306-14. doi: 10.3945/ajcn.115.129650. Epub 2016 Jun 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Kratz, MS, PhD principal investigator
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fructose-sweetened beverages, Glucose-sweetened beverages and High-fructose corn syrup-sweetened beverages in people with Low-grade Chronic Inflammation and Intestinal Permeability, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting Plasma C-reactive Protein (time frame: Beginning (day 1) and end (day 9) of each diet period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01424306, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2017.